U.S. patent application number 10/909117 was filed with the patent office on 2005-01-06 for methods and apparatus for a drug-coated stent having an expandable web structure.
This patent application is currently assigned to Abbott Laboratories Vascular Enterprises Limited. Invention is credited to Seibold, Gerd, Von Oepen, Randolf.
Application Number | 20050004662 10/909117 |
Document ID | / |
Family ID | 46277190 |
Filed Date | 2005-01-06 |
United States Patent
Application |
20050004662 |
Kind Code |
A1 |
Von Oepen, Randolf ; et
al. |
January 6, 2005 |
Methods and apparatus for a drug-coated stent having an expandable
web structure
Abstract
The present invention provides a drug-coated stent comprising a
tubular flexible body having a wall with a web structure that is
expandable from a contracted delivery configuration to deployed
configuration. The web structure comprises a plurality of
neighboring web patterns, where each web patterns is composed of
adjoining webs, and the web patterns are interconnected by
transition sections. Each adjoining web comprises a central section
interposed between two lateral sections to form concave or convex
configurations.
Inventors: |
Von Oepen, Randolf; (Los
Altos Hills, CA) ; Seibold, Gerd; (Ammerbuch,
DE) |
Correspondence
Address: |
LUCE, FORWARD, HAMILTON & SCRIPPS LLP
11988 EL CAMINO REAL, SUITE 200
SAN DIEGO
CA
92130
US
|
Assignee: |
Abbott Laboratories Vascular
Enterprises Limited
Galway
IE
|
Family ID: |
46277190 |
Appl. No.: |
10/909117 |
Filed: |
July 30, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10909117 |
Jul 30, 2004 |
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10743857 |
Dec 22, 2003 |
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10743857 |
Dec 22, 2003 |
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09742144 |
Dec 19, 2000 |
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6682554 |
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09742144 |
Dec 19, 2000 |
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09582318 |
Jun 23, 2000 |
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6602285 |
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09582318 |
Jun 23, 2000 |
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PCT/EP99/06456 |
Sep 2, 1999 |
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Current U.S.
Class: |
623/1.42 |
Current CPC
Class: |
A61F 2/91 20130101; A61F
2/915 20130101; A61F 2002/91508 20130101; A61F 2002/91558 20130101;
A61F 2002/91533 20130101 |
Class at
Publication: |
623/001.42 |
International
Class: |
A61F 002/06 |
Foreign Application Data
Date |
Code |
Application Number |
Sep 5, 1998 |
DE |
19840645.2 |
Claims
What is claimed is:
1. A stent comprising: a tubular body having proximal and distal
ends and a lumen extending therebetween, and a wall defining a web
structure configured for expansion from a collapsed delivery
configuration to an expanded deployed configuration, wherein the
web structure comprises a plurality of neighboring web patterns of
alternating concavity that extend circumferentially around the
wall, each web pattern including a plurality of arcuate webs
interconnected by bends, neighboring web patterns interconnected by
transition sections, wherein at least two of the transition
sections are separated, around the circumference of the wall, by at
least three arcuate webs; and a coating on the web structure that
comprises a therapeutic agent.
2. The stent of claim 1, wherein the therapeutic agent is chosen
from the group consisting of therapeutic agents that retard
thrombus formation, therapeutic agents that retard restenosis, and
therapeutic agents for systemic or local delivery via the blood
stream.
3. The stent of claim 1, wherein all of the transition sections are
separated by at least three arcuate webs.
4. The stent of claim 1, wherein the transition sections define
H-shaped structures.
5. The stent of claim 4, wherein at least some of the arcuate webs
span two H-shaped structures.
6. The stent of claim 4, wherein at least one of the H-shaped
structures is disposed at an angle relative to a longitudinal axis
of the stent.
7. The stent of claim 1, wherein each arcuate web comprises at
least one substantially straight section.
8. The stent of claim 7, wherein each arcuate web comprises three
substantially straight sections.
9. The stent of claim 1, wherein the at least three arcuate webs
define an S-shaped structure between interconnections to
neighboring web patterns.
10. The stent of claim 1, wherein the stent is balloon
expandable.
11. The stent of claim 1, wherein the stent comprises a deformable
material.
12. The stent of claim 11, wherein the deformable material is
chosen from the group consisting of stainless steel and
titanium.
13. The stent of claim 1, wherein the stent is self-expanding.
14. The stent of claim 1, further comprising a radiopaque
feature.
15. A stent comprising: a tubular body having proximal and distal
ends and a lumen extending therebetween, and a wall defining a web
structure configured for expansion from a delivery configuration to
a deployed configuration, wherein the web structure comprises a
plurality of neighboring web patterns of alternating concavity that
extend circumferentially around the wall, each web pattern
including a plurality of arcuate webs interconnected by bends, at
least some of the neighboring web patterns interconnected by
transition sections separated, around the circumference of the
wall, by at least two bends; and a coating on the web structure
that comprises a therapeutic agent.
16. The stent of claim 15, wherein the therapeutic agent is chosen
from the group consisting of therapeutic agents that retard
thrombus formation, therapeutic agents that retard restenosis, and
therapeutic agents for systemic or local delivery via the blood
stream.
17. The stent of claim 15, wherein the neighboring web patterns are
interconnected by transition sections separated, around the
circumference of the wall, by at least four bends.
18. The stent of claim 15, wherein the transition sections define
H-shaped structures.
19. The stent of claim 15, wherein at least some of the arcuate
webs span two H-shaped structures.
20. The stent of claim 18, wherein at least one of the H-shaped
structures is disposed at an angle relative to a longitudinal axis
of the stent.
21. The stent of claim 15, wherein each arcuate web comprises at
least one substantially straight section.
22. The stent of claim 21, wherein each arcuate web comprises three
substantially straight sections.
23. The stent of claim 15, wherein transition sections
interconnecting each web pattern to neighboring web patterns are
separated by three arcuate webs that define an S-shaped
structure.
24. The stent of claim 15, wherein the stent is balloon
expandable.
25. The stent of claim 15, wherein the stent comprises a deformable
material.
26. The stent of claim 25, wherein the deformable material is
chosen from the group consisting of stainless steel and
titanium.
27. The stent of claim 15, wherein the stent is self-expanding.
28. The stent of claim 15, further comprising a radiopaque
feature.
29. Apparatus for supporting a vessel comprising: a tube having
proximal and distal ends and a lumen extending therebetween, the
tube comprising a web structure having a collapsed state and an
expanded state, wherein the web structure comprises a plurality of
neighboring web patterns of alternating concavity, each web pattern
including a plurality of arcuate webs, at least some of the
neighboring web patterns interconnected by transition sections that
define apertures having three intercommunicating S-shaped openings;
and a coating on the web structure that comprises a therapeutic
agent.
30. The apparatus of claim 29, wherein the therapeutic agent is
chosen from the group consisting of therapeutic agents that retard
thrombus formation, therapeutic agents that retard restenosis, and
therapeutic agents for systemic or local delivery via the blood
stream.
31. The apparatus of claim 29, wherein the transition sections
define H-shaped structures that span adjacent pairs of arcuate
webs.
32. The apparatus of claim 31, wherein at least one of the H-shaped
structures is disposed at an angle relative to a longitudinal axis
of the tube.
33. The apparatus of claim 29, wherein each arcuate web comprises
at least one substantially straight section.
34. The apparatus of claim 33, wherein each arcuate web comprises
three substantially straight sections.
35. The apparatus of claim 29, wherein transition sections
interconnecting a web pattern to a neighboring web pattern are
separated by three arcuate webs that define an S-shaped
structure.
36. The apparatus of claim 29, wherein the tube is balloon
expandable.
37. The apparatus of claim 29, wherein the tube comprises a
deformable material.
38. The apparatus of claim 37, wherein the deformable material is
chosen from the group consisting of stainless steel and
titanium.
39. The apparatus of claim 29, wherein the tube is
self-expanding.
40. The apparatus of claim 29, further comprising a radiopaque
feature.
41. A stent comprising: a tube having a web structure configured to
transition between a contracted state and an expanded state,
wherein the web structure comprises a plurality of neighboring web
patterns of alternating concavity, each web pattern including a
plurality of arcuate webs interconnected by bends, neighboring web
patterns interconnected by transition sections, at least some of
the transition sections between any two neighboring web patterns
being arranged around the circumference of the tube with a common
orientation and offset by at least one intervening bend; and a
coating on the web structure that comprises a therapeutic
agent.
42. The stent of claim 41, wherein the therapeutic agent is chosen
from the group consisting of therapeutic agents that retard
thrombus formation, therapeutic agents that retard restenosis, and
therapeutic agents for systemic or local delivery via the blood
stream.
43. The stent of claim 41, wherein the arcuate webs have a first
width relative to the circumference of the tube, and the transition
sections have a second width relative to the circumference of the
tube, wherein the second width is about twice the first width.
44. The stent of claim 41, wherein the transition sections define
H-shaped structures.
45. The stent of claim 44, wherein at least one of the H-shaped
structures is disposed at an angle relative to a longitudinal axis
of the tube.
46. The stent of claim 41, wherein each arcuate web comprises at
least one substantially straight section.
47. The stent of claim 46, wherein each arcuate web comprises three
substantially straight sections.
48. The stent of claim 41, wherein transition sections
interconnecting each web pattern to neighboring web patterns are
separated by at least three arcuate webs that define an S-shaped
structure.
49. The stent of claim 41, wherein the stent is balloon
expandable.
50. The stent of claim 41, wherein the stent comprises a deformable
material.
51. The stent of claim 50, wherein the deformable material is
chosen from the group consisting of stainless steel and
titanium.
52. The stent of claim 41, wherein the stent is self-expanding.
53. The stent of claim 41, further comprising a radiopaque
feature.
54. A stent comprising: a tube having proximal and distal ends and
a lumen extending from the proximal to the distal end, the tube
comprising a web structure having a contracted delivery state and
an expanded deployed state, wherein the web structure includes a
plurality of neighboring web patterns of alternating concavity,
each web pattern including a plurality of arcuate webs, neighboring
web patterns interconnected by transition sections that span pairs
of adjacent arcuate webs, at least some of the transition sections
of neighboring patterns offset by at least one additional arcuate
web; and a coating on the web structure that comprises a
therapeutic agent.
55. The stent of claim 54, wherein the therapeutic agent is chosen
from the group consisting of therapeutic agents that retard
thrombus formation, therapeutic agents that retard restenosis, and
therapeutic agents for systemic or local delivery via the blood
stream.
56. The stent of claim 54, wherein the transition sections define
H-shaped structures.
57. The stent of claim 56, wherein at least one of the H-shaped
structures is disposed at an angle relative to a longitudinal axis
of the stent.
58. The stent of claim 54, wherein each arcuate web comprises at
least one substantially straight section.
59. The stent of claim 58, wherein each arcuate web comprises three
substantially straight sections.
60. The stent of claim 54, wherein transition sections
interconnecting a web pattern to a neighboring web pattern are
separated by three arcuate webs that define an S-shaped
structure.
61. The stent of claim 54, wherein the stent is balloon
expandable.
62. The stent of claim 54, wherein the stent comprises a deformable
material.
63. The stent of claim 62, wherein the deformable material is
chosen from the group consisting of stainless steel and
titanium.
64. The stent of claim 54, wherein the stent is self-expanding.
65. The stent of claim 54, further comprising a radiopaque
feature.
66. Apparatus for supporting a vessel comprising: a tubular body
having a web structure defining a wall, the web structure
configured to transition between a collapsed state and an expanded
state, wherein the web structure comprises a plurality of
neighboring web patterns, each web pattern including a plurality of
arcuate webs interconnected by bends, the arcuate webs of
neighboring web patterns alternating between concave and convex
forms relative to a longitudinal axis of the tubular body, the
neighboring web patterns interconnected by H-shaped transition
sections separated, around a circumference of the wall, by at least
two bends; and a coating on the web structure that comprises a
therapeutic agent.
67. The apparatus of claim 66, wherein the therapeutic agent is
chosen from the group consisting of therapeutic agents that retard
thrombus formation, therapeutic agents that retard restenosis, and
therapeutic agents for systemic or local delivery via the blood
stream.
68. The apparatus of claim 66, wherein the arcuate webs have a
first width relative to the circumference of the tubular body, and
the H-shaped transition sections have a second width, relative to
the circumference of the tubular body, about twice the first
width.
69. The apparatus of claim 66, wherein at least one of the H-shaped
transition sections is disposed at an angle relative to a
longitudinal axis of the tubular body.
70. The apparatus of claim 66, wherein each arcuate web comprises
at least one substantially straight section.
71. The apparatus of claim 71, wherein each arcuate web comprises
three substantially straight sections.
72. The apparatus of claim 66, wherein the H-shaped transition
sections interconnecting each web pattern to neighboring web
patterns are separated by three arcuate webs that define an
S-shaped structure.
73. The apparatus of claim 66, wherein the tubular body is balloon
expandable.
74. The apparatus of claim 66, wherein the tubular body comprises a
deformable material.
75. The apparatus of claim 74, wherein the deformable material is
chosen from the group consisting of stainless steel and
titanium.
76. The apparatus of claim 66, wherein the tubular body is
self-expanding.
77. The apparatus of claim 66, further comprising a radiopaque
feature.
Description
REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation application of
U.S. patent application Ser. No. 10/743,857, filed Dec. 23, 2003,
which is a continuation application of U.S. patent application Ser.
No. 09/742,144, filed Dec. 19, 2000, now U.S. Pat. No. 6,682,554,
which is a continuation-in-part application of U.S. patent
application Ser. No. 09/582,318, filed Jun. 23, 2000, now U.S. Pat.
No. 6,602,285, which claims the benefit of the filing date of
International Application PCT/EP99/06456, filed Sep. 2, 1999, which
claims priority from German application 19840645.2, filed Sep. 5,
1998.
FIELD OF THE INVENTION
[0002] The present invention relates to stents. More particularly,
the present invention relates to stents having a web structure
configured to expand from a contracted delivery configuration to an
expanded deployed configuration.
BACKGROUND OF THE INVENTION
[0003] Various stent designs are known in the art. These stents
form vascular prostheses fabricated from biocompatible materials.
Stents are typically used to expand and maintain patency of hollow
vessels, such as blood vessels or other body orifices. To this end,
the stent is often placed into a hollow vessel of a patient's body
in a contracted delivery configuration and is subsequently expanded
by suitable means, such as by a balloon catheter, to a deployed
configuration.
[0004] A stent often comprises a stent body that is expandable from
the contracted to the deployed configuration. A common drawback of
such a stent is that the stent decreases in length, or
foreshortens, along its longitudinal axis as it expands. Such
shortening is undesirable because, in the deployed configuration,
the stent may not span the entire area inside a vessel or orifice
that requires expansion and/or support.
[0005] It therefore would be desirable to provide a stent that
experiences reduced foreshortening during deployment.
[0006] It also would be desirable to provide a stent that is
flexible, even in the contracted delivery configuration.
[0007] It would be desirable to provide a stent having radial
stiffness in the expanded deployed configuration sufficient to
maintain vessel patency in a stenosed vessel.
SUMMARY OF THE INVENTION
[0008] In view of the foregoing, it is an object of the present
invention to provide a stent that experiences reduced
foreshortening during deployment.
[0009] It is another object to provide a stent that is flexible,
even in the contracted delivery configuration.
[0010] It is also an object to provide a stent having radial
stiffness in the expanded deployed configuration sufficient to
maintain vessel patency in a stenosed vessel.
[0011] These and other objects of the present invention are
accomplished by providing a stent having a tubular body whose wall
has a web structure configured to expand from a contracted delivery
configuration to an expanded deployed configuration. The web
structure comprises a plurality of neighboring web patterns having
adjoining webs. Each web has three sections: a central section
arranged substantially parallel to the longitudinal axis in the
contracted delivery configuration, and two lateral sections coupled
to the ends of the central section. The angles between the lateral
sections and the central section increase during expansion, thereby
reducing or substantially eliminating length decrease of the stent
due to expansion, while increasing a radial stiffness of the
stent.
[0012] Preferably, each of the three sections of each web is
substantially straight, the lateral sections preferably define
obtuse angles with the central section, and the three sections are
arranged relative to one another to form a concave or convex
structure. When contracted to its delivery configuration, the webs
resemble stacked or nested bowls or plates. This configuration
provides a compact delivery profile, as the webs are packed against
one another to form web patterns resembling rows of stacked
plates.
[0013] Neighboring web patterns are preferably connected to one
another by connection elements preferably formed as straight
sections. In a preferred embodiment, the connection elements extend
between adjacent web patterns from the points of interconnection
between neighboring webs within a given web pattern.
[0014] The orientation of connection elements between a pair of
neighboring web patterns preferably is the same for all connection
elements disposed between the pair. However, the orientation of
connection elements alternates between neighboring pairs of
neighboring web patterns. Thus, a stent illustratively flattened
and viewed as a plane provides an alternating orientation of
connection elements between the neighboring pairs: first upwards,
then downwards, then upwards, etc.
[0015] As will be apparent to one of skill in the art, positioning,
distribution density, and thickness of connection elements and
adjoining webs may be varied to provide stents exhibiting
characteristics tailored to specific applications. Applications may
include, for example, use in the coronary or peripheral (e.g.
renal) arteries. Positioning, density, and thickness may even vary
along the length of an individual stent in order to vary
flexibility and radial stiffness characteristics along the length
of the stent.
[0016] Stents of the present invention preferably are flexible in
the delivery configuration. Such flexibility beneficially increases
a clinician's ability to guide the stent to a target site within a
patient's vessel. Furthermore, stents of the present invention
preferably exhibit high radial stiffness in the deployed
configuration. Implanted stents therefore are capable of
withstanding compressive forces applied by a vessel wall and
maintain vessel patency. The web structure described hereinabove
provides the desired combination of flexibility in the delivery
configuration and radial stiffness in the deployed configuration.
The combination further may be achieved, for example, by providing
a stent having increased wall thickness in a first portion of the
stent and decreased wall thickness with fewer connection elements
in an adjacent portion or portions of the stent.
[0017] Depending on the material of fabrication, a stent of the
present invention may be either self-expanding or expandable by
other suitable means, for example, using a balloon catheter.
Self-expanding embodiments preferably are fabricated from a
superelastic material, such as a nickel-titanium alloy. Regardless
of the expansion mechanism used, the beneficial aspects of the
present invention are maintained: reduced shortening upon
expansion, high radial stiffness, and a high degree of
flexibility.
[0018] Methods of using stents in accordance with the present
invention are also provided.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] The above and other objects and advantages of the present
invention will be apparent upon consideration of the following
detailed description, taken in conjunction with the accompanying
drawings, in which like reference numerals refer to like parts
throughout, and in which:
[0020] FIG. 1 is a schematic isometric view illustrating the basic
structure of a stent according to the present invention;
[0021] FIG. 2 is a schematic view illustrating a web structure of a
wall of the stent of FIG. 1 in a contracted delivery
configuration;
[0022] FIG. 3 is a schematic view illustrating the web structure of
the stent of FIG. 1 in an expanded deployed configuration;
[0023] FIG. 4 is an enlarged schematic view of the web structure in
the delivery configuration;
[0024] FIG. 5 is a schematic view of an alternative web structure
of the stent of FIG. 1 having transition sections and shown in an
as-manufactured configuration;
[0025] FIGS. 6A and 6B are, respectively, a schematic view and
detailed view of an alternative embodiment of the web structure of
FIG. 5;
[0026] FIGS. 7A-7D are, respectively, schematic and detailed views
of another alternative embodiment of the web structure of the stent
of the present invention, and a cross-sectional view of the
stent;
[0027] FIGS. 8A and 8B are views further alternative embodiments of
the stent of the present application having different
interconnection patterns;
[0028] FIGS. 9A and 9B are, respectively, a schematic and detailed
view of yet another alternative embodiment of the web structure of
FIG. 5; and
[0029] FIGS. 10A-10D illustrate a method of deploying a balloon
expandable embodiment of a stent constructed in accordance with the
present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0030] Referring to FIG. 1, stent 1 comprises tubular flexible body
2. Tubular flexible body 2, in turn, comprises wall 3 having a web
structure, as described hereinbelow with respect to FIGS. 2-9.
Stent 1 and its web structure are expandable from a contracted
delivery configuration to an expanded deployed configuration.
Depending on the material of fabrication, stent 1 may be either
self-expanding or expandable using a balloon catheter. If
self-expanding, the web structure is preferably fabricated from a
superelastic material, such as a nickel-titanium alloy.
Furthermore, stent 1 preferably is fabricated from biocompatible or
biodegradable materials. It also may be radiopaque to facilitate
delivery, and it may comprise an external coating C that retards
thrombus formation or restenosis within a vessel. The coating
alternatively may deliver therapeutic agents into the patient's
blood stream.
[0031] With reference to FIGS. 2-4, a first embodiment of the web
structure of stent 1 is described. In FIGS. 2-4, wall 3 of body 2
of stent 1 is shown flattened into a plane for illustrative
purposes. FIG. 2 shows web structure 4 in a contracted delivery
configuration, with line L indicating the longitudinal axis of the
stent. Web structure 4 comprises neighboring web patterns 5 and 6
arranged in alternating, side-by-side fashion. Thus, the web
patterns seen in FIG. 2 are arranged in the sequence 5, 6, 5, 6, 5,
etc.
[0032] FIG. 2 illustrates that web patterns 5 comprise adjoining
webs 9 (concave up in FIG. 2), while web patterns 6 comprise
adjoining webs 10 (convex up in FIG. 2). Each of these webs has a
concave or convex shape resulting in a stacked plate- or bowl-like
appearance when the stent is contracted to its delivery
configuration. Webs 9 of web patterns 5 are rotated 180 degrees
with respect to webs 10 of web patterns 6, i.e., alternating
concave and convex shapes. The structure of webs 9 and 10 is
described in greater detail hereinbelow with respect to FIG. 4.
[0033] Neighboring web patterns 5 and 6 are interconnected by
connection elements 7 and 8. A plurality of connection elements 7
and 8 are provided longitudinally between each pair of web patterns
5 and 6. Multiple connection elements 7 and 8 are disposed in the
circumferential direction between adjacent webs 5 and 6. The
position, distribution density, and thickness of these pluralities
of connection elements may be varied to suit specific applications
in accordance with the present invention.
[0034] Connection elements 7 and 8 exhibit opposing orientation.
However, all connection elements 7 have the same orientation that,
as seen in FIG. 2, extends from the left side, bottom, to the right
side, top. Likewise, all connection elements 8 have the same
orientation that extends from the left side, top, to the right
side, bottom. Connection elements 7 and 8 alternate between web
patterns 5 and 6, as depicted in FIG. 2.
[0035] FIG. 3 illustrates the expanded deployed configuration of
stent 1, again with reference to a portion of web structure 4. When
stent 1 is in the expanded deployed configuration, web structure 4
provides stent 1 with high radial stiffness. This stiffness enables
stent 1 to remain in the expanded configuration while, for example,
under radial stress. Stent 1 may experience application of radial
stress when, for example, implanted into a hollow vessel in the
area of a stenosis.
[0036] FIG. 4 is an enlarged view of web structure 4 detailing a
portion of the web structure disposed in the contracted delivery
configuration of FIG. 2. FIG. 4 illustrates that each of webs 9 of
web pattern 5 comprises three sections 9a, 9b and 9c, and each of
webs 10 of web pattern 6 comprises three sections 10a, 10b and 10c.
Preferably, each individual section 9a, 9b, 9c, 10a, 10b and 10c,
has a straight configuration.
[0037] Each web 9 has a central section 9b connected to lateral
sections 9a and 9c, thus forming the previously mentioned bowl- or
plate-like configuration. Sections 9a and 9b enclose obtuse angle
.alpha.. Likewise, central section 9b and lateral section 9c
enclose obtuse angle .beta.. Sections 10a-10c of each web 10 of
each web pattern 6 are similarly configured, but are rotated 180
degrees with respect to corresponding webs 9. Where two sections 9a
or 9c, or 10a or 10c adjoin one another, third angle .gamma. is
formed (this angle is zero where the stent is in the fully
contracted position, as shown in FIG. 4).
[0038] Preferably, central sections 9b and 10b are substantially
aligned with the longitudinal axis L of the tubular stent when the
stent is in the contracted delivery configuration. The angles
between the sections of each web increase in magnitude during
expansion to the deployed configuration, except that angle .gamma.,
which is initially zero or acute, approaches a right angle after
deployment of the stent. This increase provides high radial
stiffness with reduced shortening of the stent length during
deployment. As will of course be understood by one of ordinary
skill, the number of adjoining webs that span a circumference of
the stent preferably is selected corresponding to the vessel
diameter in which the stent is intended to be implanted.
[0039] FIG. 4 illustrates that, with stent 1 disposed in the
contracted delivery configuration, webs 9 adjoin each other in an
alternating fashion and are each arranged like plates stacked into
one another, as are adjoining webs 10. FIG. 4 further illustrates
that the configuration of the sections of each web applies to all
of the webs which jointly form web structure 4 of wall 3 of tubular
body 2 of stent 1. Webs 9 are interconnected within each web
pattern 5 via rounded connection sections 12, of which one
connection section 12 is representatively labeled. Webs 10 of each
neighboring web pattern 6 are similarly configured.
[0040] FIG. 4 also once again demonstrates the arrangement of
connection elements 7 and 8. Connection elements 7, between a web
pattern 5 and a neighboring web pattern 6, are disposed obliquely
relative to the longitudinal axis L of the stent with an
orientation A, which is the same for all connection elements 7.
Orientation A is illustrated by a straight line that generally
extends from the left side, bottom, to the right side, top of FIG.
4. Likewise, the orientation of all connection elements 8 is
illustrated by line B that generally extends from the left side,
top, to the right side, bottom of FIG. 4. Thus, an alternating A,
B, A, B, etc., orientation is obtained over the entirety of web
structure 4 for connection elements between neighboring web
patterns.
[0041] Connection elements 7 and 8 are each configured as a
straight section that passes into a connection section 11 of web
pattern 5 and into a connection section 11' of web pattern 6. This
is illustratively shown in FIG. 4 with a connection element 7
extending between neighboring connection sections 11 and 11',
respectively. It should be understood that this represents a
general case for all connection elements 7 and 8.
[0042] Since each web consists of three interconnected sections
that form angles .alpha. and .beta. with respect to one another,
which angles are preferably obtuse in the delivery configuration,
expansion to the deployed configuration of FIG. 3 increases the
magnitude of angles .alpha. and .beta.. This angular increase
beneficially provides increased radial stiffness in the expanded
configuration. Thus, stent 1 may be flexible in the contracted
delivery configuration to facilitate delivery through tortuous
anatomy, and also may exhibit sufficient radial stiffness in the
expanded configuration to ensure vessel patency, even when deployed
in an area of stenosis. The increase in angular magnitude also
reduces and may even substantially eliminate length decrease of the
stent due to expansion, thereby decreasing a likelihood that stent
1 will not completely span a target site within a patient's vessel
post-deployment.
[0043] The stent of FIG. 4 is particularly well-suited for use as a
self-expanding stent when manufactured, for example, from a shape
memory alloy such as nickel-titanium. In this case, web patterns 5
and 6 preferably are formed by laser-cutting a tubular member,
wherein adjacent webs 9 and 10 are formed using slit-type cuts.
Only the areas circumferentially located between connection members
7 and 8 (shaded area D in FIG. 4) require removal of areas of the
tubular member. These areas also may be removed from the tubular
member using laser cutting techniques.
[0044] Referring now to FIG. 5, an alternative embodiment of the
web structure of stent 1 is described. FIG. 5 shows the alternative
web structure in an as-manufactured configuration. The basic
pattern of the embodiment of FIG. 5 corresponds to that of the
embodiment of FIGS. 2-4. Thus, this alternative embodiment also
relates to a stent having a tubular flexible body with a wall
having a web structure configured to expand from a contracted
delivery configuration to the deployed configuration.
[0045] Likewise, the web structure again comprises a plurality of
neighboring web patterns, of which two are illustratively labeled
in FIG. 5 as web patterns 5 and 6. Web patterns 5 and 6 are again
provided with adjoining webs 9 and 10, respectively. Each of webs 9
and 10 is subdivided into three sections, and reference is made to
the discussion provided hereinabove, particularly with respect to
FIG. 4. As will of course be understood by one of skill in the art,
the stent of FIG. 5 will have a smaller diameter when contracted
(or crimped) for delivery, and may have a larger diameter than
illustrated in FIG. 5 when deployed (or expanded) in a vessel.
[0046] The embodiment of FIG. 5 differs from the previous
embodiment by the absence of connection elements between web
patterns. In FIG. 5, web patterns are interconnected to neighboring
web patterns by transition sections 13, as shown by integral
transition section 13 disposed between sections 9c and 10c.
Symmetric, inverted web patterns are thereby obtained in the region
of transition sections 13. To enhance stiffness, transition
sections 13 preferably have a width greater than twice the width of
webs 9 or 10.
[0047] As seen in FIG. 5, every third neighboring pair of webs 9
and 10 is joined by an integral transition section 13. As will be
clear to those of skill in the art, the size and spacing of
transition sections 13 may be altered in accordance with the
principles of the present invention.
[0048] An advantage of the web structure of FIG. 5 is that it
provides stent 1 with compact construction coupled with a high
degree of flexibility in the delivery configuration and high
load-bearing capabilities in the deployed configuration.
Furthermore, FIG. 5 illustrates that, as with connection elements 7
and 8 of FIG. 4, transition sections 13 have an alternating
orientation and are disposed obliquely relative to the longitudinal
axis of the stent (shown by reference line L). FIG. 5 also
illustrates that, especially in the deployed configuration, an
H-like configuration of transition sections 13 with adjoining web
sections is obtained.
[0049] The stent of FIG. 5 is well-suited for use as a
balloon-expandable stent, and may be manufactured from stainless
steel alloys. Unlike the stent of FIG. 4, which is formed in the
contracted delivery configuration, the stent of FIG. 5 preferably
is formed in a partially deployed configuration by removing the
shaded areas D' between webs 9 and 10 using laser-cutting or
chemical etching techniques. In this case, central sections 9b and
10b are substantially aligned with the longitudinal axis L of the
stent when the stent is crimped onto the dilatation balloon of a
delivery system.
[0050] Referring now to FIGS. 6 and 7, alternative embodiments of
the web structure of FIG. 5 are described. These web structures
differ from the embodiment of FIG. 5 in the spacing of the
transition sections. Web structure 15 of FIGS. 6A and 6B provides a
spacing of transition sections 16 suited for use in the coronary
arteries. FIG. 6A shows the overall arrangement, while FIG. 6B
provides a detail view of region A of FIG. 6A. Other arrangements
and spacings will be apparent to those of skill in the art and fall
within the scope of the present invention.
[0051] Web structure 17 of FIGS. 7A-7D provides stent 1 with a
variable wall thickness and a distribution density or spacing of
transition sections 16 suited for use in the renal arteries. FIG.
7A shows the arrangement of web structure 17 along the length of
stent 1, and demonstrates the spacing of transition sections 18.
FIGS. 7C and 7D provide detail views of regions A and B,
respectively, of FIG. 7A, showing how the spacing and shape of the
webs that make up web structure 17 change as stent 1 changes along
its length. In particular, as depicted (not to scale) in FIG. 7D,
stent 1 has first thickness t.sub.1 for first length L.sub.1 and
second thickness t.sub.2 for second length L.sub.2.
[0052] The variation in thickness, rigidity and number of struts of
the web along the length of the stent of FIGS. 7A-7D facilitates
use of the stent in the renal arteries. For example, the thicker
region L.sub.1 includes more closely spaced and sturdier struts to
provide a high degree of support in the ostial region, while the
thinner region L.sub.2 includes fewer and thinner struts to provide
greater flexibility to enter the renal arteries. For such intended
applications, region L.sub.1 preferably has a length of about 6-8
mm and a nominal thickness t.sub.1 of 0.21 mm, and region L.sub.2
has a length of about 5 mm and a nominal thickness t.sub.2 of about
0.15 mm.
[0053] As depicted in FIGS. 7A-7D, the reduction in wall thickness
may occur as a step along the exterior of the stent, such as may be
obtained by grinding or chemical etching. One of ordinary skill in
the art will appreciate, however, that the variation in thickness
may occur gradually along the length of the stent, and that the
reduction in wall thickness could be achieved by alternatively
removing material from the interior surface of the stent, or both
the exterior and interior surfaces of the stent.
[0054] In FIGS. 8A and 8B, additional embodiments of web structures
of the present invention, similar to FIG. 5, are described, in
which line L indicates the direction of the longitudinal axis of
the stent. In FIG. 5, every third neighboring pair of webs is
joined by an integral transition section 13, and no set of struts
9a-9c or 10a-10c directly joins two transition sections 13. In the
embodiment of FIG. 8A, however, integral transition sections 20 are
arranged in a pattern so that the transition sections span either
four or three adjacent webs. For example, the portion indicated as
22 in FIG. 8A includes three consecutively joined transition
sections, spanning four webs. In the circumferential direction,
portion 22 alternates with the portion indicated at 24, which
includes two consecutive transition sections, spanning three
webs.
[0055] By comparison, the web pattern depicted in FIG. 8B includes
only portions 24 that repeat around the circumference of the stent,
and span only three webs at a time. As will be apparent to one of
ordinary skill, other arrangements of integral transition regions
13 may be employed, and may be selected on an empirical basis to
provide any desired degree of flexibility and trackability in the
contracted delivery configuration, and suitable radial strength in
the deployed configuration.
[0056] Referring now to FIGS. 9A and 9B, a further alternative
embodiment of the stent of FIG. 8B is described, in which the
transition sections are formed with reduced thickness. Web
structure 26 comprises transition sections 27 disposed between
neighboring web patterns. Sections 27 are thinner and comprise less
material than transition sections 20 of the embodiment of FIG. 8B,
thereby enhancing flexibility without significant reduction in
radial stiffness.
[0057] Referring now to FIGS. 10A-10D, a method of using a balloon
expandable embodiment of stent 1 is provided. Stent 1 is disposed
in a contracted delivery configuration over balloon 30 of balloon
catheter 32. As seen in FIG. 10A, the distal end of catheter 32 is
delivered to a target site T within a patient's vessel V using, for
example, well-known percutaneous techniques. Stent 1 or portions of
catheter 32 may be radiopaque to facilitate positioning within the
vessel. Target site T may, for example, comprise a stenosed region
of vessel V at which an angioplasty procedure has been
conducted.
[0058] In FIG. 10B, balloon 30 is inflated to expand stent 1 to the
deployed configuration in which it contacts the wall of vessel V at
target site T. Notably, the web pattern of stent 1 described
hereinabove minimizes a length decrease of stent 1 during
expansion, thereby ensuring that stent 1 covers all of target site
T. Balloon 30 is then deflated, as seen in FIG. 1.degree. C., and
balloon catheter 32 is removed from vessel V, as seen in FIG.
10D.
[0059] Stent 1 is left in place within the vessel. Its web
structure provides radial stiffness that maintains stent 1 in the
expanded configuration and minimizes restenosis. Stent 1 may also
comprise external coating C configured to retard restenosis or
thrombosis formation around the stent. Coating C may alternatively
deliver therapeutic agents into the patient's blood stream.
[0060] Although preferred illustrative embodiments of the present
invention are described hereinabove, it will be evident to one
skilled in the art that various changes and modifications may be
made therein without departing from the invention. It is intended
in the appended claims to cover all such changes and modifications
that fall within the true spirit and scope of the invention.
* * * * *